Ten-year follow-up results of perioperative chemotherapy with doxorubicin and ifosfamide for high-grade soft-tissue sarcoma of the extremities: Japan Clinical Oncology Group study JCOG0304

Kazuhiro Tanaka, Junki Mizusawa, Norifumi Naka, Akira Kawai, Hirohisa Katagiri, Toru Hiruma, Yoshihiro Matsumoto, Hiroyuki Tsuchiya, Robert Nakayama, Hiroshi Hatano, Makoto Emori, Munenori Watanuki, Yukihiro Yoshida, Takeshi Okamoto, Satoshi Abe, Kunihiro Asanuma, Ryohei Yokoyama, Hiroaki Hiraga, Tsukasa Yonemoto, Takeshi MoriiKeisuke Ae, Akihito Nagano, Hideki Yoshikawa, Haruhiko Fukuda, Toshifumi Ozaki, Yukihide Iwamoto

Research output: Contribution to journalArticle

Abstract

Background: Soft-tissue sarcomas (STS) are rare malignant tumors those are resistant to chemotherapy. We have previously reported the 3-year follow-up result on the efficacy of perioperative chemotherapy with doxorubicin (DXR) and ifosfamide (IFM) for high-risk STS of the extremities (JCOG0304). In the present study, we analyzed the 10-year follow-up results of JCOG0304. Methods: Patients with operable, high-risk STS (T2bN0M0, AJCC 6th edition) of the extremities were treated with 3 courses of preoperative and 2 courses of postoperative chemotherapy, which consisted of 60 mg/m2 of DXR plus 10 g/m2 of IFM over a 3-week interval. The primary study endpoint was progression-free survival (PFS) estimated by Kaplan-Meier methods. Prognostic factors were evaluated by univariable and multivariable Cox proportional hazards model. Results: A total of 72 patients were enrolled between March 2004 and September 2008, with 70 of these patients being eligible. The median follow-up period was 10.0 years for all eligible patients. Local recurrence and distant metastasis were observed in 5 and 19 patients, respectively. The 10-year PFS was 65.7% (95% CI: 53.4-75.5%) with no PFS events being detected during the last 5 years of follow-up. The 10-year overall survival was 78.1% (95% CI: 66.3-86.2%). Secondary malignancy was detected in 6 patients. The subgroup analysis demonstrated that there was significant difference in survival with regard to primary tumor size. Conclusions: Only a few long-term results of clinical trials for perioperative chemotherapy treatment of STS have been reported. Our results demonstrate that the 10-year outcome of JCOG0304 for patients with operable, high-risk STS of the extremities was stable and remained favorable during the last 5 years of follow-up. Trial registration: This trial was registered at the UMIN Clinical Trials Registry as C000000096 on August 30, 2005.

Original languageEnglish
Article number890
JournalBMC Cancer
Volume19
Issue number1
DOIs
Publication statusPublished - 2019 Sep 6

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Ifosfamide
Medical Oncology
Sarcoma
Doxorubicin
Japan
Extremities
Drug Therapy
Disease-Free Survival
Clinical Trials
Neoplasms
Survival
Proportional Hazards Models
Registries
Neoplasm Metastasis
Recurrence

Keywords

  • 10-year follow-up
  • Doxorubicin and ifosfamide
  • Extremity
  • Perioperative chemotherapy
  • Soft tissue sarcoma
  • Survival

ASJC Scopus subject areas

  • Genetics
  • Oncology
  • Cancer Research

Cite this

Ten-year follow-up results of perioperative chemotherapy with doxorubicin and ifosfamide for high-grade soft-tissue sarcoma of the extremities : Japan Clinical Oncology Group study JCOG0304. / Tanaka, Kazuhiro; Mizusawa, Junki; Naka, Norifumi; Kawai, Akira; Katagiri, Hirohisa; Hiruma, Toru; Matsumoto, Yoshihiro; Tsuchiya, Hiroyuki; Nakayama, Robert; Hatano, Hiroshi; Emori, Makoto; Watanuki, Munenori; Yoshida, Yukihiro; Okamoto, Takeshi; Abe, Satoshi; Asanuma, Kunihiro; Yokoyama, Ryohei; Hiraga, Hiroaki; Yonemoto, Tsukasa; Morii, Takeshi; Ae, Keisuke; Nagano, Akihito; Yoshikawa, Hideki; Fukuda, Haruhiko; Ozaki, Toshifumi; Iwamoto, Yukihide.

In: BMC Cancer, Vol. 19, No. 1, 890, 06.09.2019.

Research output: Contribution to journalArticle

Tanaka, K, Mizusawa, J, Naka, N, Kawai, A, Katagiri, H, Hiruma, T, Matsumoto, Y, Tsuchiya, H, Nakayama, R, Hatano, H, Emori, M, Watanuki, M, Yoshida, Y, Okamoto, T, Abe, S, Asanuma, K, Yokoyama, R, Hiraga, H, Yonemoto, T, Morii, T, Ae, K, Nagano, A, Yoshikawa, H, Fukuda, H, Ozaki, T & Iwamoto, Y 2019, 'Ten-year follow-up results of perioperative chemotherapy with doxorubicin and ifosfamide for high-grade soft-tissue sarcoma of the extremities: Japan Clinical Oncology Group study JCOG0304', BMC Cancer, vol. 19, no. 1, 890. https://doi.org/10.1186/s12885-019-6114-2
Tanaka, Kazuhiro ; Mizusawa, Junki ; Naka, Norifumi ; Kawai, Akira ; Katagiri, Hirohisa ; Hiruma, Toru ; Matsumoto, Yoshihiro ; Tsuchiya, Hiroyuki ; Nakayama, Robert ; Hatano, Hiroshi ; Emori, Makoto ; Watanuki, Munenori ; Yoshida, Yukihiro ; Okamoto, Takeshi ; Abe, Satoshi ; Asanuma, Kunihiro ; Yokoyama, Ryohei ; Hiraga, Hiroaki ; Yonemoto, Tsukasa ; Morii, Takeshi ; Ae, Keisuke ; Nagano, Akihito ; Yoshikawa, Hideki ; Fukuda, Haruhiko ; Ozaki, Toshifumi ; Iwamoto, Yukihide. / Ten-year follow-up results of perioperative chemotherapy with doxorubicin and ifosfamide for high-grade soft-tissue sarcoma of the extremities : Japan Clinical Oncology Group study JCOG0304. In: BMC Cancer. 2019 ; Vol. 19, No. 1.
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abstract = "Background: Soft-tissue sarcomas (STS) are rare malignant tumors those are resistant to chemotherapy. We have previously reported the 3-year follow-up result on the efficacy of perioperative chemotherapy with doxorubicin (DXR) and ifosfamide (IFM) for high-risk STS of the extremities (JCOG0304). In the present study, we analyzed the 10-year follow-up results of JCOG0304. Methods: Patients with operable, high-risk STS (T2bN0M0, AJCC 6th edition) of the extremities were treated with 3 courses of preoperative and 2 courses of postoperative chemotherapy, which consisted of 60 mg/m2 of DXR plus 10 g/m2 of IFM over a 3-week interval. The primary study endpoint was progression-free survival (PFS) estimated by Kaplan-Meier methods. Prognostic factors were evaluated by univariable and multivariable Cox proportional hazards model. Results: A total of 72 patients were enrolled between March 2004 and September 2008, with 70 of these patients being eligible. The median follow-up period was 10.0 years for all eligible patients. Local recurrence and distant metastasis were observed in 5 and 19 patients, respectively. The 10-year PFS was 65.7{\%} (95{\%} CI: 53.4-75.5{\%}) with no PFS events being detected during the last 5 years of follow-up. The 10-year overall survival was 78.1{\%} (95{\%} CI: 66.3-86.2{\%}). Secondary malignancy was detected in 6 patients. The subgroup analysis demonstrated that there was significant difference in survival with regard to primary tumor size. Conclusions: Only a few long-term results of clinical trials for perioperative chemotherapy treatment of STS have been reported. Our results demonstrate that the 10-year outcome of JCOG0304 for patients with operable, high-risk STS of the extremities was stable and remained favorable during the last 5 years of follow-up. Trial registration: This trial was registered at the UMIN Clinical Trials Registry as C000000096 on August 30, 2005.",
keywords = "10-year follow-up, Doxorubicin and ifosfamide, Extremity, Perioperative chemotherapy, Soft tissue sarcoma, Survival",
author = "Kazuhiro Tanaka and Junki Mizusawa and Norifumi Naka and Akira Kawai and Hirohisa Katagiri and Toru Hiruma and Yoshihiro Matsumoto and Hiroyuki Tsuchiya and Robert Nakayama and Hiroshi Hatano and Makoto Emori and Munenori Watanuki and Yukihiro Yoshida and Takeshi Okamoto and Satoshi Abe and Kunihiro Asanuma and Ryohei Yokoyama and Hiroaki Hiraga and Tsukasa Yonemoto and Takeshi Morii and Keisuke Ae and Akihito Nagano and Hideki Yoshikawa and Haruhiko Fukuda and Toshifumi Ozaki and Yukihide Iwamoto",
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month = "9",
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journal = "BMC Cancer",
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TY - JOUR

T1 - Ten-year follow-up results of perioperative chemotherapy with doxorubicin and ifosfamide for high-grade soft-tissue sarcoma of the extremities

T2 - Japan Clinical Oncology Group study JCOG0304

AU - Tanaka, Kazuhiro

AU - Mizusawa, Junki

AU - Naka, Norifumi

AU - Kawai, Akira

AU - Katagiri, Hirohisa

AU - Hiruma, Toru

AU - Matsumoto, Yoshihiro

AU - Tsuchiya, Hiroyuki

AU - Nakayama, Robert

AU - Hatano, Hiroshi

AU - Emori, Makoto

AU - Watanuki, Munenori

AU - Yoshida, Yukihiro

AU - Okamoto, Takeshi

AU - Abe, Satoshi

AU - Asanuma, Kunihiro

AU - Yokoyama, Ryohei

AU - Hiraga, Hiroaki

AU - Yonemoto, Tsukasa

AU - Morii, Takeshi

AU - Ae, Keisuke

AU - Nagano, Akihito

AU - Yoshikawa, Hideki

AU - Fukuda, Haruhiko

AU - Ozaki, Toshifumi

AU - Iwamoto, Yukihide

PY - 2019/9/6

Y1 - 2019/9/6

N2 - Background: Soft-tissue sarcomas (STS) are rare malignant tumors those are resistant to chemotherapy. We have previously reported the 3-year follow-up result on the efficacy of perioperative chemotherapy with doxorubicin (DXR) and ifosfamide (IFM) for high-risk STS of the extremities (JCOG0304). In the present study, we analyzed the 10-year follow-up results of JCOG0304. Methods: Patients with operable, high-risk STS (T2bN0M0, AJCC 6th edition) of the extremities were treated with 3 courses of preoperative and 2 courses of postoperative chemotherapy, which consisted of 60 mg/m2 of DXR plus 10 g/m2 of IFM over a 3-week interval. The primary study endpoint was progression-free survival (PFS) estimated by Kaplan-Meier methods. Prognostic factors were evaluated by univariable and multivariable Cox proportional hazards model. Results: A total of 72 patients were enrolled between March 2004 and September 2008, with 70 of these patients being eligible. The median follow-up period was 10.0 years for all eligible patients. Local recurrence and distant metastasis were observed in 5 and 19 patients, respectively. The 10-year PFS was 65.7% (95% CI: 53.4-75.5%) with no PFS events being detected during the last 5 years of follow-up. The 10-year overall survival was 78.1% (95% CI: 66.3-86.2%). Secondary malignancy was detected in 6 patients. The subgroup analysis demonstrated that there was significant difference in survival with regard to primary tumor size. Conclusions: Only a few long-term results of clinical trials for perioperative chemotherapy treatment of STS have been reported. Our results demonstrate that the 10-year outcome of JCOG0304 for patients with operable, high-risk STS of the extremities was stable and remained favorable during the last 5 years of follow-up. Trial registration: This trial was registered at the UMIN Clinical Trials Registry as C000000096 on August 30, 2005.

AB - Background: Soft-tissue sarcomas (STS) are rare malignant tumors those are resistant to chemotherapy. We have previously reported the 3-year follow-up result on the efficacy of perioperative chemotherapy with doxorubicin (DXR) and ifosfamide (IFM) for high-risk STS of the extremities (JCOG0304). In the present study, we analyzed the 10-year follow-up results of JCOG0304. Methods: Patients with operable, high-risk STS (T2bN0M0, AJCC 6th edition) of the extremities were treated with 3 courses of preoperative and 2 courses of postoperative chemotherapy, which consisted of 60 mg/m2 of DXR plus 10 g/m2 of IFM over a 3-week interval. The primary study endpoint was progression-free survival (PFS) estimated by Kaplan-Meier methods. Prognostic factors were evaluated by univariable and multivariable Cox proportional hazards model. Results: A total of 72 patients were enrolled between March 2004 and September 2008, with 70 of these patients being eligible. The median follow-up period was 10.0 years for all eligible patients. Local recurrence and distant metastasis were observed in 5 and 19 patients, respectively. The 10-year PFS was 65.7% (95% CI: 53.4-75.5%) with no PFS events being detected during the last 5 years of follow-up. The 10-year overall survival was 78.1% (95% CI: 66.3-86.2%). Secondary malignancy was detected in 6 patients. The subgroup analysis demonstrated that there was significant difference in survival with regard to primary tumor size. Conclusions: Only a few long-term results of clinical trials for perioperative chemotherapy treatment of STS have been reported. Our results demonstrate that the 10-year outcome of JCOG0304 for patients with operable, high-risk STS of the extremities was stable and remained favorable during the last 5 years of follow-up. Trial registration: This trial was registered at the UMIN Clinical Trials Registry as C000000096 on August 30, 2005.

KW - 10-year follow-up

KW - Doxorubicin and ifosfamide

KW - Extremity

KW - Perioperative chemotherapy

KW - Soft tissue sarcoma

KW - Survival

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U2 - 10.1186/s12885-019-6114-2

DO - 10.1186/s12885-019-6114-2

M3 - Article

C2 - 31492159

AN - SCOPUS:85071896887

VL - 19

JO - BMC Cancer

JF - BMC Cancer

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